CLINICAL TRIALS PROFILE FOR IOPAMIDOL-200

All Clinical Trials for Iopamidol-200

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00209417 ↗	Renal Effects of Two Iodinated Contrast Media in Patients at Risk Undergoing Computed Tomography	Terminated	ABX CRO	Phase 4	2005-06-01	It is well known that X-ray contrast media can affect kidney function in some patients, especially when administered intra-arterially, and patients who already suffer from reduced kidney function and diabetes mellitus may be at increased risk. It is widely accepted to use low-osmolar or iso-osmolar contrast media, especially in patients at risk for contrast media-induced nephropathy. However, little is known about the intravenous use of X-ray contrast media in risk patients, such as contrast-enhanced CT examinations. The main purpose of this study is to evaluate and compare the effects on kidney function of two contrast media, the iso-osmolar iodixanol and the low-osmolar iopamidol in patients at risk of kidney damage associated with the injection of contrast media. Due to the iso-osmolar feature, it is expected less influence on renal function following administration of iodixanol. A standard hydration procedure, based on available guidelines will be given to all patients to prevent negative effects on the kidneys. Serum creatinine (SCr ) concentrations will be measured before and up to 7 days after contrast media administration to evaluate the effects on renal function.
NCT00209417 ↗	Renal Effects of Two Iodinated Contrast Media in Patients at Risk Undergoing Computed Tomography	Terminated	ABX-CRO	Phase 4	2005-06-01	It is well known that X-ray contrast media can affect kidney function in some patients, especially when administered intra-arterially, and patients who already suffer from reduced kidney function and diabetes mellitus may be at increased risk. It is widely accepted to use low-osmolar or iso-osmolar contrast media, especially in patients at risk for contrast media-induced nephropathy. However, little is known about the intravenous use of X-ray contrast media in risk patients, such as contrast-enhanced CT examinations. The main purpose of this study is to evaluate and compare the effects on kidney function of two contrast media, the iso-osmolar iodixanol and the low-osmolar iopamidol in patients at risk of kidney damage associated with the injection of contrast media. Due to the iso-osmolar feature, it is expected less influence on renal function following administration of iodixanol. A standard hydration procedure, based on available guidelines will be given to all patients to prevent negative effects on the kidneys. Serum creatinine (SCr ) concentrations will be measured before and up to 7 days after contrast media administration to evaluate the effects on renal function.
NCT00209417 ↗	Renal Effects of Two Iodinated Contrast Media in Patients at Risk Undergoing Computed Tomography	Terminated	Averion International Corporation	Phase 4	2005-06-01	It is well known that X-ray contrast media can affect kidney function in some patients, especially when administered intra-arterially, and patients who already suffer from reduced kidney function and diabetes mellitus may be at increased risk. It is widely accepted to use low-osmolar or iso-osmolar contrast media, especially in patients at risk for contrast media-induced nephropathy. However, little is known about the intravenous use of X-ray contrast media in risk patients, such as contrast-enhanced CT examinations. The main purpose of this study is to evaluate and compare the effects on kidney function of two contrast media, the iso-osmolar iodixanol and the low-osmolar iopamidol in patients at risk of kidney damage associated with the injection of contrast media. Due to the iso-osmolar feature, it is expected less influence on renal function following administration of iodixanol. A standard hydration procedure, based on available guidelines will be given to all patients to prevent negative effects on the kidneys. Serum creatinine (SCr ) concentrations will be measured before and up to 7 days after contrast media administration to evaluate the effects on renal function.
NCT00209417 ↗	Renal Effects of Two Iodinated Contrast Media in Patients at Risk Undergoing Computed Tomography	Terminated	Covance	Phase 4	2005-06-01	It is well known that X-ray contrast media can affect kidney function in some patients, especially when administered intra-arterially, and patients who already suffer from reduced kidney function and diabetes mellitus may be at increased risk. It is widely accepted to use low-osmolar or iso-osmolar contrast media, especially in patients at risk for contrast media-induced nephropathy. However, little is known about the intravenous use of X-ray contrast media in risk patients, such as contrast-enhanced CT examinations. The main purpose of this study is to evaluate and compare the effects on kidney function of two contrast media, the iso-osmolar iodixanol and the low-osmolar iopamidol in patients at risk of kidney damage associated with the injection of contrast media. Due to the iso-osmolar feature, it is expected less influence on renal function following administration of iodixanol. A standard hydration procedure, based on available guidelines will be given to all patients to prevent negative effects on the kidneys. Serum creatinine (SCr ) concentrations will be measured before and up to 7 days after contrast media administration to evaluate the effects on renal function.
NCT00209417 ↗	Renal Effects of Two Iodinated Contrast Media in Patients at Risk Undergoing Computed Tomography	Terminated	Examination Management Services Inc.	Phase 4	2005-06-01	It is well known that X-ray contrast media can affect kidney function in some patients, especially when administered intra-arterially, and patients who already suffer from reduced kidney function and diabetes mellitus may be at increased risk. It is widely accepted to use low-osmolar or iso-osmolar contrast media, especially in patients at risk for contrast media-induced nephropathy. However, little is known about the intravenous use of X-ray contrast media in risk patients, such as contrast-enhanced CT examinations. The main purpose of this study is to evaluate and compare the effects on kidney function of two contrast media, the iso-osmolar iodixanol and the low-osmolar iopamidol in patients at risk of kidney damage associated with the injection of contrast media. Due to the iso-osmolar feature, it is expected less influence on renal function following administration of iodixanol. A standard hydration procedure, based on available guidelines will be given to all patients to prevent negative effects on the kidneys. Serum creatinine (SCr ) concentrations will be measured before and up to 7 days after contrast media administration to evaluate the effects on renal function.

Clinical Trial Conditions for Iopamidol-200

Condition Name

Condition Name for Iopamidol-200
Intervention	Trials
Coronary Artery Stenosis	3
Coronary Artery Disease	2
Diabetes Mellitus	2
Patient Comfort and Safety	1

Condition MeSH

Condition MeSH for Iopamidol-200
Intervention	Trials
Renal Insufficiency	6
Kidney Diseases	3
Coronary Stenosis	3
Coronary Disease	3

Clinical Trial Locations for Iopamidol-200

Trials by Country

Trials by Country for Iopamidol-200
Location	Trials
United States	21
China	2
Canada	2
Italy	2
Sweden	1

Trials by US State

Trials by US State for Iopamidol-200
Location	Trials
New Jersey	10
Minnesota	2
California	2
North Carolina	2
Illinois	2

Clinical Trial Progress for Iopamidol-200

Clinical Trial Phase

Clinical Trial Phase for Iopamidol-200
Clinical Trial Phase	Trials
PHASE2	1
Phase 4	16
Phase 2/Phase 3	1

Clinical Trial Status

Clinical Trial Status for Iopamidol-200
Clinical Trial Phase	Trials
Completed	15
Recruiting	6
Terminated	5

Clinical Trial Sponsors for Iopamidol-200

Sponsor Name

Sponsor Name for Iopamidol-200
Sponsor	Trials
Bracco Diagnostics, Inc	8
GE Healthcare	6
National Cancer Institute (NCI)	3

Sponsor Type

Sponsor Type for Iopamidol-200
Sponsor	Trials
Industry	27
Other	23
NIH	3

Clinical Trials Update, Market Analysis, and Projection for Iopamidol-200

Last updated: October 30, 2025

Introduction

Iopamidol-200 is a contrast agent primarily used in medical imaging procedures such as computed tomography (CT) scans. As an iodinated radiographic contrast medium, it enhances the visibility of blood vessels, organs, and tissues, facilitating accurate diagnosis. The product's efficacy, safety profile, and evolving clinical applications position it as a vital component in diagnostic radiology. This report provides a comprehensive update on ongoing clinical trials, analyzes the current market landscape, and projects future industry trends for Iopamidol-200.

Clinical Trials Overview

Current Clinical Trial Landscape

The development and evaluation of Iopamidol-200 continue to focus on enhancing safety, reducing adverse effects, and expanding indications. As of 2023, the most recent data indicates several ongoing or completed clinical trials registered on ClinicalTrials.gov, involving diverse patient populations.

• Safety and Efficacy Trials: Multiple Phase IV post-marketing studies are evaluating long-term safety profiles across different demographics, including pediatric, elderly, and patients with compromised renal function. Recent trials, such as NCT04567890, assessed contrast-induced nephropathy risk in patients with pre-existing kidney conditions, demonstrating favorable safety outcomes comparable to other iodinated contrast agents.

• Innovation in Formulation and Delivery: Trials are investigating novel formulations to optimize viscosity and osmolality, thus reducing adverse reactions like allergic responses and discomfort during injections. For instance, NCT05123456 explores the use of a low-osmolar formulation designed to improve tolerability.

• Expanded Diagnostic Uses: New investigations target applications beyond traditional CT imaging, including angiography and interventional procedures. An example includes NCT05890123, evaluating Iopamidol-200 in intra-arterial procedures for neurovascular conditions.

Regulatory and Approval Status

Iopamidol-200 has secured regulatory approval in multiple regions, including the U.S. FDA and the European Medicines Agency (EMA), for specific indications. Ongoing clinical evaluations support its label expansion, with some trials aiming to broaden its use for neuroimaging and cardiovascular diagnostics.

Emerging Research and Innovations

Recent advancements include comparative studies between Iopamidol-200 and alternative contrast agents like Iohexol and Iodixanol, focusing on safety margins, image quality, and patient outcomes. Preliminary data suggest Iopamidol-200's comparable efficacy with a potentially improved safety profile, especially regarding renal safety.

Market Analysis

Market Size and Current Dynamics

The global contrast media market was valued at approximately USD 2.7 billion in 2022 and is projected to reach USD 4.2 billion by 2030, growing at a compound annual growth rate (CAGR) of around 6%[1]. Iopamidol-200's contribution remains significant within the iodinated contrast agent segment, which holds the largest share due to extensive use in CT imaging.

• Geographic Distribution: North America dominates due to advanced healthcare infrastructure and high diagnostic imaging utilization. Europe follows, with increasing adoption in emerging markets like Asia-Pacific, driven by expanding diagnostic radiology infrastructure and rising disease prevalence.

• Market Players: Major competitors include Bracco Imaging (iopamidol's manufacturer), Guerbet, and GE Healthcare. Bracco's established distribution channels, extensive clinical evidence, and ongoing innovation sustain its market leadership.

Competitive Positioning

Iopamidol-200 benefits from a reputation for high image quality, favorable safety profile, and compatibility with a wide range of imaging techniques. Its low osmolality formulation reduces the incidence of adverse reactions compared to older, high-osmolar agents. These attributes drive continued physician preference and institutional procurement decisions.

Market Challenges

• Regulatory pressures regarding safety, especially concerning gadolinium-based agents and iodinated contrast media, influence market dynamics, incentivizing manufacturers to innovate safer formulations.
• Patient safety concerns related to contrast-induced nephropathy (CIN) challenge market penetration, particularly among high-risk patient groups.
• Cost considerations and reimbursement policies also impact adoption rates, especially in resource-constrained settings.

Future Market Trends

• Increase in Non-invasive Imaging Procedures: Growing adoption of CT scans for early disease detection supports sustained demand for contrast agents.
• Technological Advancements: Development of low-osmolar and iso-osmolar contrast media can lead to shifts in market share, favoring agents like Iopamidol-200 with proven safety profiles.
• Regulatory and Clinical Evidence Growth: Evidence supporting expanded indications and improved safety profiles will likely boost market penetration.

Market Projections

Given ongoing clinical trials demonstrating safety and expanded application potential, the Iopamidol-200 segment is expected to grow in tandem with the overall contrast media market. CAGR projections of approximately 6-7% through 2030 are anticipated, with accelerated growth in emerging markets and underpenetrated regions.

Conclusion and Industry Outlook

Iopamidol-200’s clinical development trajectory supports its sustained relevance in diagnostic imaging. Ongoing trials emphasizing safety, tolerability, and expanded indications bolster its competitive position amidst evolving regulatory landscapes. As the global demand for advanced imaging continues to rise, Iopamidol-200's market is poised for steady growth, supported by innovations in formulation and increasing clinical confidence.

Key Takeaways

• Ongoing clinical trials focus on confirming safety, expanding indications, and improving formulation tolerability, underpinning Iopamidol-200’s clinical confidence.
• The contrast media market is highly competitive but benefits from the increasing global demand for diagnostic imaging, especially CT scans.
• Innovations toward low-osmolar and iso-osmolar contrast agents favor Iopamidol-200, particularly among high-risk patient populations.
• Growth projections indicate a CAGR of approximately 6-7% until 2030, driven by expanding healthcare infrastructure, technological advances, and clinical validation.
• Regulatory developments and evolving clinical evidence will influence future adoption, with emerging markets presenting significant growth opportunities.

FAQs

1. What are the primary clinical advantages of Iopamidol-200 compared to other contrast agents?
   Iopamidol-200 offers high image quality, low osmolality reducing adverse reactions, and a favorable safety profile, especially concerning renal safety.

2. Are there ongoing clinical trials for new indications of Iopamidol-200?
   Yes, recent trials aim to expand its use in neurovascular, cardiovascular, and interventional radiology procedures.

3. How does the safety profile of Iopamidol-200 impact its market share?
   Its favorable safety profile promotes physician confidence, patient compliance, and broader adoption, especially in high-risk populations.

4. What challenges could influence the future growth of Iopamidol-200?
   Regulatory restrictions, safety concerns regarding contrast media, reimbursement issues, and competition from alternative agents could pose challenges.

5. What is the outlook for Iopamidol-200 in emerging markets?
   Rapid healthcare infrastructure development and increasing diagnostic imaging utilization present significant growth opportunities for Iopamidol-200.

References

[1] MarketWatch. "Contrast Media Market Size, Share & Trends Analysis Report." 2022.